Product code GNW
- Device name
- Antisera, Cf, Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3330
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-10-21 |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | 2009-08-28 |
| K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | 2008-12-23 |
| K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | 2006-11-20 |
| K022713 | DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | 2002-12-18 |
| K003204 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT | Intracel Corp. | 2000-11-07 |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | Light Diagnostics | 1998-04-08 |
| K973954 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1997-12-22 |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1996-12-26 |
| K942172 | INFLUENZA A ANTIGEN TEST | Neogenex | 1994-07-06 |
| K942174 | INFLUENZA B ANITGEN TEST | Neogenex | 1994-06-30 |
| K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST | Gull Laboratories, Inc. | 1991-12-17 |
| K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST | Gull Laboratories, Inc. | 1991-12-13 |
| K896635 | VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY | Baxter Healthcare Corp | 1990-02-02 |
| K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
| K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| ENTIINFG02900 | NovaLisa Influenza Virus A IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| ENTIINFG03000 | NovaLisa Influenza Virus B IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| ENTIINFG0290 | NovaLisa Influenza Virus A IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| ENTIINFG0300 | NovaLisa Influenza Virus B IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| 05032384503070 | IMAGEN RESPIRATORY SCREEN POS CON SLIDE | OXOID LIMITED | 2024-07-03 |
| 05032384503841 | IMAGEN Respiratory Screen Kit | OXOID LIMITED | 2024-06-19 |
| 04048474037937 | Influenza Virus A IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474037968 | Influenza Virus B IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 00840239037930 | Influenza Virus A IgG ELISA | DRG International Inc | 2023-08-25 |
| 00840239037961 | Influenza Virus B IgG ELISA | DRG International Inc | 2023-08-25 |
| B350GSD0130090 | Influenza A IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-12-07 |
| 04053252270239 | Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent | EMD Millipore Corporation | 2022-12-01 |
| 04053252373435 | Light Diagnostics ™ Influenza A & B Control Slides | EMD Millipore Corporation | 2022-12-01 |
| 04053252473722 | Light Diagnostics ™ Influenza B Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04053252789229 | Light Diagnostics ™ Influenza A & B Control Slide | EMD Millipore Corporation | 2022-11-30 |
| 04053252368165 | Light Diagnostics ™ SimulFluor® Flu A/Flu B Reagent | EMD Millipore Corporation | 2022-11-30 |
| 04053252320439 | Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal Antibody | EMD Millipore Corporation | 2022-11-30 |
| 04053252330094 | Light Diagnostics ™ Influenza B Monoclonal Antibody | EMD Millipore Corporation | 2022-11-29 |
| 04053252470226 | Light Diagnostics ™ Influenza A Monoclonal Antibody | EMD Millipore Corporation | 2022-11-29 |
| 04053252367588 | Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay | EMD Millipore Corporation | 2022-11-28 |
| 08436037124594 | Light Diagnostics™ Influenza A and B DFA Kit | EMD Millipore Corporation | 2022-11-28 |
| B350GSD0130100 | Influenza B IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-10-07 |
| 00404847437935 | Influenza Virus A IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847437966 | Influenza Virus B IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 30014613330288 | D3 Ultra | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330295 | D3 Ultra | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330301 | D3 Ultra | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330318 | D3 Ultra | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330325 | D3 Ultra | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |
| 30014613330349 | D3 Ultra | DIAGNOSTIC HYBRIDS, INC. | 2019-03-07 |